Trial Outcomes & Findings for Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) (NCT NCT05026710)
NCT ID: NCT05026710
Last Updated: 2025-10-28
Results Overview
This is a 3-item survey which participants select a response for each item from 1=no pain to 5=very severe for intensity of their pain. The sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 7-10 days after surgery.
COMPLETED
NA
224 participants
Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
2025-10-28
Participant Flow
For the purposes of this trial, enrollment was defined as those who were randomized, remained eligible prior to stent placement, and received the study intervention.
Participant milestones
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
109
|
|
Overall Study
COMPLETED
|
107
|
108
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Overall Study
No longer met eligibility criteria
|
3
|
1
|
Baseline Characteristics
\*missing baseline PROMIS Pain Intensity due to non-response.
Baseline characteristics by cohort
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=110 Participants
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=109 Participants
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=110 Participants
|
59 years
n=109 Participants
|
59 years
n=219 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=110 Participants
|
57 Participants
n=109 Participants
|
116 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=110 Participants
|
52 Participants
n=109 Participants
|
103 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Caucasion
|
95 Participants
n=110 Participants
|
94 Participants
n=109 Participants
|
189 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=110 Participants
|
8 Participants
n=109 Participants
|
12 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=110 Participants
|
1 Participants
n=109 Participants
|
3 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Unknown/Refused
|
5 Participants
n=110 Participants
|
5 Participants
n=109 Participants
|
10 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=110 Participants
|
1 Participants
n=109 Participants
|
5 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
101 Participants
n=110 Participants
|
100 Participants
n=109 Participants
|
201 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=110 Participants
|
2 Participants
n=109 Participants
|
2 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Unknown/refused
|
9 Participants
n=110 Participants
|
7 Participants
n=109 Participants
|
16 Participants
n=219 Participants
|
|
Stone Location
Renal Only
|
59 Participants
n=110 Participants
|
59 Participants
n=109 Participants
|
118 Participants
n=219 Participants
|
|
Stone Location
Ureter/Ureter + Renal
|
48 Participants
n=110 Participants
|
49 Participants
n=109 Participants
|
97 Participants
n=219 Participants
|
|
Stone Location
Withdrawn due to ineligibility
|
3 Participants
n=110 Participants
|
1 Participants
n=109 Participants
|
4 Participants
n=219 Participants
|
|
Stone Size
|
8 mm
n=110 Participants
|
9 mm
n=109 Participants
|
9 mm
n=219 Participants
|
|
PROMIS Pain Intensity
|
51.4 units on a scale
n=106 Participants • \*missing baseline PROMIS Pain Intensity due to non-response.
|
54.8 units on a scale
n=107 Participants • \*missing baseline PROMIS Pain Intensity due to non-response.
|
54.8 units on a scale
n=213 Participants • \*missing baseline PROMIS Pain Intensity due to non-response.
|
|
PROMIS Pain Interference
|
56.1 units on a scale
n=105 Participants • \*missing baseline PROMIS Pain Interference due to non-response
|
59.1 units on a scale
n=107 Participants • \*missing baseline PROMIS Pain Interference due to non-response
|
57.1 units on a scale
n=212 Participants • \*missing baseline PROMIS Pain Interference due to non-response
|
|
LURN SI-10 Baseline Measures
|
8 units on a scale
n=106 Participants • \*missing baseline LURN SI-10 due to non-response.
|
7 units on a scale
n=107 Participants • \*missing baseline LURN SI-10 due to non-response.
|
7 units on a scale
n=213 Participants • \*missing baseline LURN SI-10 due to non-response.
|
PRIMARY outcome
Timeframe: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.Population: Participants were only included in the analysis if they completed both the baseline survey and the follow-up survey
This is a 3-item survey which participants select a response for each item from 1=no pain to 5=very severe for intensity of their pain. The sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 7-10 days after surgery.
Outcome measures
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=98 Participants
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=96 Participants
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days
|
4.28 T-score
Interval 1.26 to 7.29
|
2.92 T-score
Interval -0.07 to 5.91
|
PRIMARY outcome
Timeframe: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.Population: Participants were only included in the analysis if they completed both the baseline survey and the follow-up survey.
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 7-10 days after surgery.
Outcome measures
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=98 Participants
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=96 Participants
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days
|
4.62 T-Score
Interval 1.76 to 7.47
|
3.24 T-Score
Interval 0.23 to 6.24
|
SECONDARY outcome
Timeframe: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.Population: Participants were only analyzed for this outcome if the completed the baseline, 7-10 day, and 4-6 week questionnaires
This is a 3-item survey which participants select a response for each item from 1=no pain to 5=very severe for intensity of their pain. The sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 4-6 weeks after surgery.
Outcome measures
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=93 Participants
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=85 Participants
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 4 to 6 Weeks
|
-6.60 T-Score
Interval -9.4 to -3.79
|
-9.93 T-Score
Interval -13.1 to -6.76
|
SECONDARY outcome
Timeframe: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.Population: Participants were only analyzed for this outcome if the completed the baseline, 7-10 day, and 4-6 week questionnaires
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 4-6 weeks after surgery.
Outcome measures
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=93 Participants
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=85 Participants
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks
|
-6.38 T-Score
Interval -9.18 to -3.58
|
-8.08 T-Score
Interval -11.29 to -4.87
|
SECONDARY outcome
Timeframe: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.Population: Participants were only included in the analysis if they completed both the baseline survey and the day 7-10 follow-up survey
The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Responses for each item range from 0 to 4 or 0 to 3 and are then summed for total scores ranging from 0 to 38 (higher scores = worse symptoms/bother). Change is defined as the difference in LURN SI-10 total score from baseline to 7-10 days after surgery.
Outcome measures
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=98 Participants
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=96 Participants
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days
|
2.53 units on a scale
Interval 1.42 to 3.64
|
2.90 units on a scale
Interval 1.69 to 4.12
|
SECONDARY outcome
Timeframe: : Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.Population: Participants were only analyzed for this outcome if the completed the baseline, 7-10 day, and 4-6 week questionnaires
The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Responses for each item range from 0 to 4 or 0 to 3 and are then summed for total scores ranging from 0 to 38 (higher scores = worse symptoms/bother). Change is defined as the difference in LURN SI-10 total score from baseline to 4-6 weeks after surgery.
Outcome measures
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=93 Participants
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=85 Participants
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Change in NIH LURN SI-10 Scores at 4 to 6 Weeks
|
-2.54 units on a scale
Interval -3.56 to -1.52
|
-3.23 units on a scale
Interval -4.36 to -2.1
|
SECONDARY outcome
Timeframe: up to 30 daysWinRatio composite healthcare utilization score ranges from 0 to 5 based on each participants highest level of healthcare utilization, with higher score indicating a worse outcome: 0=no HCU, 1=phone call or EMR message, 2=office visit, 3= Emergency Department visit, 4=Unplanned Hospitalization, 5=Hospitalization with ICU care
Outcome measures
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=107 Participants
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=108 Participants
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Composite Healthcare Utilization Metric Within 30 Days (WinRatio)
|
0 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: up to 60 daysPopulation: Only includes participants who received imaging (CT, US, and/or KUB) and were assessed for hydronephrosis within 60 days of URS
Results reflect the participants whose imaging indicated either new or worsening hydronephrosis in the operative renal unit.
Outcome measures
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=37 Participants
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=47 Participants
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Abnormal Imaging Findings Within 60 Days
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 60 daysPopulation: Only includes participants who received imaging (CT, US, and/or KUB) within 60 days of URS
Results reflect the participants who had no residual renal stone following treatment based on postoperative imaging.
Outcome measures
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=56 Participants
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=56 Participants
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Stone-free Rates Within 60 Days
|
33 Participants
|
32 Participants
|
Adverse Events
Silicone (Coloplast Imajin Hydro) Ureteral Stent
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
Serious adverse events
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=107 participants at risk
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=108 participants at risk
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/107 • Up to 60 days
|
0.93%
1/108 • Up to 60 days
|
|
Injury, poisoning and procedural complications
Urinary Tract Infection (UTI)
|
0.93%
1/107 • Up to 60 days
|
0.93%
1/108 • Up to 60 days
|
|
Renal and urinary disorders
Hematuria
|
0.93%
1/107 • Up to 60 days
|
0.93%
1/108 • Up to 60 days
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/107 • Up to 60 days
|
0.93%
1/108 • Up to 60 days
|
|
Renal and urinary disorders
Flank Pain
|
1.9%
2/107 • Up to 60 days
|
0.00%
0/108 • Up to 60 days
|
|
Renal and urinary disorders
Nausea
|
0.93%
1/107 • Up to 60 days
|
0.00%
0/108 • Up to 60 days
|
Other adverse events
| Measure |
Silicone (Coloplast Imajin Hydro) Ureteral Stent
n=107 participants at risk
Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed.
|
Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer).
n=108 participants at risk
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
|
|---|---|---|
|
Reproductive system and breast disorders
Vulvovaginitis
|
0.00%
0/107 • Up to 60 days
|
0.93%
1/108 • Up to 60 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/107 • Up to 60 days
|
0.93%
1/108 • Up to 60 days
|
|
Renal and urinary disorders
Infected and obstructing ureteral stone with AKI
|
0.93%
1/107 • Up to 60 days
|
0.93%
1/108 • Up to 60 days
|
|
Renal and urinary disorders
Stent Displacement
|
2.8%
3/107 • Up to 60 days
|
0.00%
0/108 • Up to 60 days
|
|
Renal and urinary disorders
Urinary Frequency
|
1.9%
2/107 • Up to 60 days
|
0.93%
1/108 • Up to 60 days
|
|
Renal and urinary disorders
Flank Pain
|
4.7%
5/107 • Up to 60 days
|
4.6%
5/108 • Up to 60 days
|
|
Renal and urinary disorders
Hematuria
|
0.93%
1/107 • Up to 60 days
|
0.93%
1/108 • Up to 60 days
|
|
Infections and infestations
Fever
|
0.00%
0/107 • Up to 60 days
|
0.93%
1/108 • Up to 60 days
|
|
Infections and infestations
Urinary Tract Infection
|
0.93%
1/107 • Up to 60 days
|
2.8%
3/108 • Up to 60 days
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/107 • Up to 60 days
|
1.9%
2/108 • Up to 60 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.93%
1/107 • Up to 60 days
|
2.8%
3/108 • Up to 60 days
|
|
Musculoskeletal and connective tissue disorders
Fall resulting in arthroplasty
|
0.93%
1/107 • Up to 60 days
|
0.00%
0/108 • Up to 60 days
|
|
General disorders
COVID
|
0.93%
1/107 • Up to 60 days
|
0.00%
0/108 • Up to 60 days
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.93%
1/107 • Up to 60 days
|
0.00%
0/108 • Up to 60 days
|
|
Respiratory, thoracic and mediastinal disorders
PE without acure cor pulmonale
|
0.93%
1/107 • Up to 60 days
|
0.00%
0/108 • Up to 60 days
|
|
Renal and urinary disorders
Obstructing Stone Fragment on Opposite Side
|
0.93%
1/107 • Up to 60 days
|
0.00%
0/108 • Up to 60 days
|
|
Gastrointestinal disorders
Diarrhea and dehydration
|
0.93%
1/107 • Up to 60 days
|
0.00%
0/108 • Up to 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place